The University of Texas M. D. Anderson Cancer Center Clinical and Translational Research Center (CTRC), founded in 1990, serves as the primary institutional site for patient-oriented, protocol-based, innovative clinical and translational research. The CTRC gives highest priority to studies that seek to answer biologically based research questions while maintaining the highest quality patient care. By bringing together clinical and laboratory staff in a tight working relationship with state-of-the-art facilities, the CTRC provides outstanding nursing care, full phlebotomy and laboratory services for pharmacokinetic studies, and rigorous research infrastructure and oversight. In calendar year 2001, there were 4,296 patient visits with 1,097 specimens obtained for analysis. Currently, there are 121 active protocols administered in the CTRC. In April 2002, as a result of a major donation for institutional research enhancement, the CTRC was fully re-organized with new leadership structure, expanded staffing, and increased clinical capability. The entire 18,000 sq ft 10th floor outpatient unit, which contains the CTRC as well as the Ambulatory Treatment Center (ATC), is due to be completely renovated by October 2002. The newly designed 6,150 sq ft 17-bed CTRC is directly adjacent to the new Ambulatory Treatment Center (ATC) to maximize nursing care, laboratory support, and staff utilization. Laboratory and administrative offices are strategically placed to facilitate the acquisition and processing of blood and other specimens. This design facilitates the investigation of drug metabolism, safety, and efficacy - critical components of modem cancer research, especially for phase I and phase II clinical trials. The expanded CTRC will include 31 full time staff: 2 unit clerks, 2 patient care assistants, 2 pharmacists, an Administrative Manager, 11 phlebotomists, and 13 RNs, including an Assistant Nurse Manager, Research Nurse Supervisor, and an Advanced Practice Nurse. The Medical Director supervises day-to-day operations together with the Nurse Manager and the other administrative staff. Governance is performed by the Director of the CTRC, the Director of Clinical Pharmacology and the Head of Pathology and Laboratory Medicine in concert with a 22-member Steering Committee. New services include a full-function Access protocol database with which to update and monitor all research studies, including information on correlative sample collection, storage, and shipment to analytical laboratories. The new organizational structure will provide 16 hours per day of expanded phlebotomy and specimen processing services. Future plans include implementation of a graphic-based informatics system for protocol management and a local intranet-based system to monitor sample collection, storage and shipment status in real time. The funds requested in this application will support the critical administrative and round-the-clock phlebotomy services needed to conduct impeccable modem translational research.